Multimodal Instrumented Assessment of Post-stroke Elbow

Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions - a Randomized Controlled Trial Protocol

The proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol is a randomized controlled trial consisting of a 4-week functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke; Spasticity, Muscle; Upper Limb
• Intervention / Treatment: Device: Neuroexsos elbow module

Detailed Description

The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy towards functional recovery. However, the current clinical evaluation and treatment of this stiffness (and underlying muscle spasticity) are severely limited by their dependence on subjective evaluation and manual limb mobilization, thus rendering the evaluation imprecise and the treatment insufficiently tailored to the specific pathologies and residual capabilities of individual patients. To address these needs, the proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol provide a functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Federico Posteraro, MD; Phone Number: +39 05846057061; Email: federico.posteraro@uslnordovest.toscana.it
• Study Contact Backup: Name: Nicola Vitiello, Prof; Phone Number: +39 050883111; Email: nicola.vitiello@santannapisa.it

Study Locations

• Italy
  • Lucca
    • Camaiore, Lucca, Italy, 55041
      • Ospedale Versilia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Upper limb spasticity due to neurological impairment;
• Cognitive abilities sufficient for understanding instructions;
• Absence of severe pain assessed as Visual Analogic Score (VAS) < 4 (range 0-10).

Exclusion Criteria:

• Unstable general clinical conditions;
• Inability to keep sitting posture;
• Tendon retractions limiting upper limb joints range of motion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic treatment; Patients receive 4 weeks of elbow rehabilitation treatment provided by the NEEM robotic elbow exoskeleton	Device: Neuroexsos elbow module; The treatment group will be further divided into two levels (sub-groups), based on pathological severity: Level 1 corresponds to an FM score equal or below 28, and Level 2 with FM greater than 28. The two sub-groups will receive different combinations of robotically assisted passive mobilization (PM) and active mobilization (AM) treatment modalities, according to their differing clinical needs
Active Comparator: Conventional treatment; Patients receive 4 weeks of elbow conventional rehabilitation treatment matched in time	Device: Neuroexsos elbow module; The treatment group will be further divided into two levels (sub-groups), based on pathological severity: Level 1 corresponds to an FM score equal or below 28, and Level 2 with FM greater than 28. The two sub-groups will receive different combinations of robotically assisted passive mobilization (PM) and active mobilization (AM) treatment modalities, according to their differing clinical needs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the score of the upper-extremity section of Fugl-Meyer assessment scale (FM 0-66) higher score means better	It is a clinical scale used for the assessment of motor function in stroke patients	before and within 1 week after 4 weeks of treatment
Change in the score of Modified Ashworth Scale (MAS 0-5 scoring 1+ as 2 for statistical analysis) higher score means worse	It is a clinical scale for spasticity assessment	Before and within 1 week after 4 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum Extension Torque (MET)	It corresponds to the maximum torque value recorded during a static hold phase at the maximum reached extension angle	Before and within 1 week after 4 weeks of treatment
Change in Zero Torque Angle (ZTA)	It is the angular value corresponding to null torque exerted by the robot; in this configuration, flexor and extensor torques are equal and opposite and the system is ideally not applying any force to hold the elbow in position, which has reached its equilibrium point	Before and within 1 week after 4 weeks of treatment
Change in Joint Impedance (JIMP)	A measure of the limb resistance to muscle elongation, extracted as the ratio between joint torque and joint angular position for constant, slow-speed movements, the main contribution to the joint impedance can be identified in the joint stiffness (i.e. rigidity).	Before and within 1 week after 4 weeks of treatment

Collaborators and Investigators

• Sponsor: Azienda USL Toscana Nord Ovest
• Collaborators: Scuola Superiore Sant'Anna Pisa

Publications and helpful links

General Publications

• Pilla A, Trigili E, McKinney Z, Fanciullacci C, Malasoma C, Posteraro F, Crea S, Vitiello N. Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions-A Randomized Controlled Trial Protocol. Front Neurol. 2020 Oct 22;11:587293. doi: 10.3389/fneur.2020.587293. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 22, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Robotics; Upper extremities; EMG
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity
• Other Study ID Numbers: NEEM20160118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No